title: Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial.
abstract: BACKGROUND
  In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN) within 24 hours of onset may reduce the number of infections as compared to the current practice of starting an oral diet and EN if necessary at 3-4 days after admission.
  
  
  METHODS
  The PYTHON trial is a randomised controlled, parallel-group, superiority multicenter trial. Patients with predicted severe acute pancreatitis (Imrie-score ≥ 3 or APACHE-II score ≥ 8 or CRP > 150 mg/L) will be randomised to EN within 24 hours or an oral diet and EN if necessary, after 72 hours after hospital admission.During a 3-year period, 208 patients will be enrolled from 20 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of mortality or infections (bacteraemia, infected pancreatic or peripancreatic necrosis, pneumonia) during hospital stay or within 6 months following randomisation. Secondary endpoints include other major morbidity (e.g. new onset organ failure, need for intervention), intolerance of enteral feeding and total costs from a societal perspective.
  
  
  CONCLUSIONS
  The PYTHON trial is designed to show that a very early (< 24 h) start of EN reduces the combined endpoint of mortality or infections as compared to the current practice of an oral diet and EN if necessary at around 72 hours after admission for predicted severe acute pancreatitis.
  
  
  BACKGROUND
  ISRCTN: ISRCTN18170985.
authors.affiliation: Dept, of OR/Evidence Based Surgery, Radboud University Nijmegen Medical Centre, PO 9101, 6500 HB Nijmegen; The Netherlands.
authors.forename: Olaf J
authors.initials: OJ
authors.lastname: Bakker
authors.forename: Hjalmar C
authors.initials: HC
authors.lastname: van Santvoort
authors.forename: Sandra
authors.initials: S
authors.lastname: van Brunschot
authors.forename: Usama
authors.initials: U
authors.lastname: Ahmed Ali
authors.forename: Marc G
authors.initials: MG
authors.lastname: Besselink
authors.forename: Marja A
authors.initials: MA
authors.lastname: Boermeester
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Bollen
authors.forename: Koop
authors.initials: K
authors.lastname: Bosscha
authors.forename: Menno A
authors.initials: MA
authors.lastname: Brink
authors.forename: Cornelis H
authors.initials: CH
authors.lastname: Dejong
authors.forename: Erwin J
authors.initials: EJ
authors.lastname: van Geenen
authors.forename: Harry
authors.initials: H
authors.lastname: van Goor
authors.forename: Joos
authors.initials: J
authors.lastname: Heisterkamp
authors.forename: Alexander P
authors.initials: AP
authors.lastname: Houdijk
authors.forename: Jeroen M
authors.initials: JM
authors.lastname: Jansen
authors.forename: Thom M
authors.initials: TM
authors.lastname: Karsten
authors.forename: Eric R
authors.initials: ER
authors.lastname: Manusama
authors.forename: Vincent B
authors.initials: VB
authors.lastname: Nieuwenhuijs
authors.forename: Bert
authors.initials: B
authors.lastname: van Ramshorst
authors.forename: Alexander F
authors.initials: AF
authors.lastname: Schaapherder
authors.forename: George P
authors.initials: GP
authors.lastname: van der Schelling
authors.forename: Marcel Bm
authors.initials: MB
authors.lastname: Spanier
authors.forename: Adriaan
authors.initials: A
authors.lastname: Tan
authors.forename: Juda
authors.initials: J
authors.lastname: Vecht
authors.forename: Bas L
authors.initials: BL
authors.lastname: Weusten
authors.forename: Ben J
authors.initials: BJ
authors.lastname: Witteman
authors.forename: Louis M
authors.initials: LM
authors.lastname: Akkermans
authors.forename: Hein G
authors.initials: HG
authors.lastname: Gooszen
mesh_terms: D018806:APACHE; D000208:Acute Disease; D001424:Bacterial Infections / Q000209:etiology / Q000517:prevention & control; D004750:Enteral Nutrition / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D009426:Netherlands; D010195:Pancreatitis / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D012107:Research Design; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome